Skin aging
Conditions
Interventions
Cosmetic formulation for skin with signs of aging, containing niacinamide, associated with aesthetic procedures using 5 MHz therapeutic ultrasound. The 56-day double-blind, controlled study aimed to a
(B) cosmetic formulation 1
(C) cosmetic formulation 2
(D) cosmetic formulation 3
(E) placebo formulation plus unfocused ultrasound, and (F) cosmetic formulation 3 plus unfocused ultrasound group. The use of the formulations was carried out at home, once a day, always at the same t
E02.565.280.945
Sponsors
Faculdade de Ciências Farmacêuticas da Unicamp
Faculdade de Ciências Farmacêuticas da Unicamp
Eligibility
Sex/Gender
Female
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: Women; aged 30 to 65 years; agree with the study conditions; ability to understand and follow the instructions; agree to avoid sun exposure during the study; do not use other cosmetics in the test region throughout the study; be available to attend laboratory sessions on scheduled days; do not wash the test skin region for at least 2 hours before analysis; not having performed aesthetic procedures for at least 3 months
Exclusion criteria
Exclusion criteria: Lack of cognitive capacity; not understanding the method to be used; be pregnant or breastfeeding; present lesions compatible with active infectious diseases; history of aesthetic plastic surgery in the facial region; history of use of botulinum toxin, fillers or threads; history of recent facial aesthetic treatment, in less than 3 months; have generalized dermatological diseases, such as psoriasis or vitiligo; allergy to any cosmetic product; present systemic diseases with proven effects on the skin; be on continuous treatment with corticosteroids, antihistamines, diuretics, antibiotics, analgesics, anticoagulants, which directly or indirectly affect the skin; carry out immunosuppressive therapy; being treated for endocrine disorders; oophorectomy or hysterectomy; present allergic reactions in the test region during the study; have lesions, wounds, scars, tattoos or piercings in the test region of the skin; presence of metal pins or plates in the craniofacial region; neoplasms, cancer, growing epiphyseal plate and venous thrombosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that the individual interventions (cosmetic product and therapeutic ultrasound) alone will promote beneficial effects on the participants' skin health, such as improvements in the skin barrier, hydration, sebum levels, collagen production, and the reduction of spots and fine lines. The combination of the cosmetic product with therapeutic ultrasound is expected to bring even greater benefits, promoting a synergistic effect with an increase of at least 30% when compared to separate interventions. Data were obtained through the determination of the water content of the stratum corneum, assessment of the viscoelastic properties of the skin, measurement of skin sebum content, determination of transepidermal water loss (TEWL), assessment of dermal density, and high-resolution ultrasound analysis of the epidermis | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected | — |
Countries
Brazil
Contacts
Public ContactGislaine Leonardi
Faculdade de Ciências Farmacêuticas da Unicamp
Outcome results
None listed